Safety and Tolerability of Vildagliptin Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00646542

Collaborator

(none)

525

Enrollment

Locations

Arms

43.8

Patients Per Site

Study Details

Study Description

Brief Summary

This clinical trial is designed to provide additional information on the safety and tolerability of vildagliptin (50 mg once daily (qd)) when used in patients with type 2 diabetes mellitus (T2DM) and moderate or severe renal insufficiency.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Vildagliptin Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

525 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Multi-center, Randomized, Double-blind Clinical Trial to Evaluate the Safety and Tolerability of 24 Weeks Treatment With (50 mg qd) Versus Placebo in Patients With Type 2 Diabetes and Moderate or Severe Renal Insufficiency

Study Start Date :

Mar 1, 2005

Actual Primary Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Vildagliptin Other Names: Galvus
Placebo Comparator: 2	Drug: Placebo

Arm

Intervention/Treatment

Experimental: 1

Drug: Vildagliptin

Other Names:

Galvus

Placebo Comparator: 2

Drug: Placebo

Outcome Measures

Primary Outcome Measures

To evaluate the safety and tolerability in patients with T2DM and moderate or severe renal insufficiency over 24 weeks of treatment [24 weeks]

Secondary Outcome Measures

To assess concentration levels of vildagliptin and its metabolites in patients with T2DM and moderate or severe renal insufficiency. [24 weeks]
To explore the efficacy of vildagliptin (50 mg qd) versus placebo in patients with T2DM and moderate or severe renal insufficiency. [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

History T2DM
Moderate or Severe Renal Impairment

Exclusion Criteria:

Glucose > 270 mg/dL (>15 mmol/L)

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Locations

	City	Country
1	Buenos Aires	Argentina
2	Heidelberg Heights	Australia
3	Winnipeg	Canada
4	Cartago	Costa Rica
5	Tampere	Finland
6	Angers	France
7	Dormagen	Germany
8	Chennai	India
9	Oslo	Norway
10	Saint Petersburg	Russian Federation
11	Alicante	Spain
12	Lund	Sweden